Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- Bipolar Disorder
- Cardiovascular Disease
- Major Depressive Disorder
- Psychosis NOS
- Schizoaffective Disorder
- Schizophrenia
- Serious Mental Illness
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 89 years
- Gender
- Both males and females
Description
By design, all subjects in the Intervention arm will start by being under treatment. During the course of follow-up, we expect that some will stay consistently on treatment, some will discontinue treatment (become non-adherent), while others will make transitions on and off treatment in various patt...
By design, all subjects in the Intervention arm will start by being under treatment. During the course of follow-up, we expect that some will stay consistently on treatment, some will discontinue treatment (become non-adherent), while others will make transitions on and off treatment in various patterns. In contrast, by design, subjects in the Usual Treatment (control) arm do not start on treatment; however, some will initiate treatment as a result of usual clinical care, e.g., primary care physician initiation. At any point we will be comparing two binary outcomes (on or off treatment) and will use standard methods for comparing two proportions to test statistical significance and get confidence intervals for the difference in the percent on treatment in the two arms. Participants who are ineligible for randomization will be followed similarly to participants in the Usual Treatment Arm, in a third, non-randomized group, which will be excluded from the primary analysis.
Tracking Information
- NCT #
- NCT02188121
- Collaborators
- Michael J. Gill Mental Health Clinic
- The Massachusetts Mental Health Center
- Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
- The Edinburg Center, Bedford MA
- Investigators
- Principal Investigator: Dost Ongur, MD PhD Mclean Hospital